General Position Summary/Purpose:
Counsel – Legal Healthcare/Regulatory is responsible for providing legal, regulatory and healthcare compliance counsel and handling a variety of business transactions, and commercial contracting. Serve as Counsel for IMBRUVICA and frequently interact with and provide substantive advice to cross-functional departments including Commercial, Medical Affairs, and Regulatory Affairs. Provide counsel concerning a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, government reimbursement, and interactions with healthcare professionals.
Key Accountabilities/Core Job Responsibilities:
- Provide legal advice and assistance for the development of policies, training and conduct training.
- Responsible for compliance with applicable Corporate Policies and procedures.
- Work cross functionally with various departments to meet business objectives.
- Responsible for preparing, reviewing and negotiating commercial agreements, 3rd party vendor agreements, service agreements, pharmacy agreements, consulting agreements and other corporate agreements.
- Develop knowledge of Pharmacyclics’ business and supported client areas.
- Represent Pharmacyclics externally to customers, suppliers, competitors or government agencies.
- Resolve legal issues using negotiation skills and legal expertise.
- Help select and direct the work of outside counsel, define project objectives and manage project
- Assist Pharmacyclics Head of Legal on matters of significant importance.
- Serve as recognized source, for the business as well as other attorneys, regarding innovative ideas in complex areas of law, business, or technology.
- Be committed to meeting patient unmet needs and be energized by rising to new challenges and coming up with creative solutions to serve patients.
- Be energized by challenging and interesting legal work and novel business problems.
- Stay abreast of changes in laws that affect client areas.
- Clearly define project objectives with capable management.
- Identify unmet needs and future legal issues and proactively proposes strategies to optimize outcomes and results for the company and manage risk.
- Have excellent communication skills.
- Ability to prioritize and manage multiple projects.
- Minimum 5+ years of relevant experience.
- JD required.
- Must meet the professional licensing requirement of the state in which they practice.
- Experience with pharmaceutical/biotech companies required, and educational background in applicable scientific field is a plus.
- Experience with Market Access/Managed Health Care matters is desirable, but not required.